Status:
ACTIVE_NOT_RECRUITING
Diet Impact on Hepatic Transcriptomics and Lipidomics in Pre-diabetes
Lead Sponsor:
Laval University
Conditions:
Pre-diabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver diseases, affecting 25% to 30% of the global population and nearly one third of the population in North America. NAFLD is defi...
Eligibility Criteria
Inclusion
- Males and females 18 to 60 years of age.
- Non-smoker
- Waist circumference \> 102 cm for men and \> 88 cm for women.
- Plasma triglyceride levels \> 1,7 mmol/L at the screening visit.
- Fasting plasma glucose levels \> 6,1 mmol/L at the screening visit.
- Fasting plasma insulin levels above the upper limit of normal at the screening visit.
- Subjects must be willing to give written informed consent and able to adhere to the diet schedule and visit schedule.
- Patients should be otherwise healthy, without abnormal renal function or coagulation.
Exclusion
- Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded.
- Subjects will be excluded if they have cardiovascular disease (CHD, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (eg. steroids, beta blockers, thiazide diuretics, other lipid lowering agents, significant alcohol intake etc.).
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
- Individuals with a history of mental instability, drug or alcohol abuse within the past 2 years or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study.
- Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation.
- Known impairment of renal function (creatinine \>2.0 mg/dL), dysproteinemia, nephrotic syndrome, or other renal disease.
- Subjects with coagulopathy (prothrombin time \[PT\] or partial thromboplastin time \[PTT\] at Visit 1 higher than 1.5 times control).
- Patients who are known to have tested positive for human immunodeficiency virus (HIV).
- Patients who have used any investigational drug within 30 days of the first clinic visit.
- Diabetic patients are excluded from the study. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins. Clinically euthyroid subjects on replacement doses of thyroid hormone are eligible for enrollment.
Key Trial Info
Start Date :
June 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05965973
Start Date
June 9 2023
End Date
December 31 2025
Last Update
October 9 2024
Active Locations (1)
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1
Institute of Nutrition and Functional Foods (INAF)
Québec, Quebec, Canada, G1V 0A6